FDA draft guidance clarifies risk disclosures in drug ads

FDA is seeking comments on revised draft guidance clarifying requirements for disclosures in consumer-directed print prescription drug advertisements and promotional materials, specifically in the consumer brief summary and the directions for use.

In the draft, FDA encourages manufacturers to include in the consumer brief summary plain, comprehensible language describing only a drug's most serious and most common risks, including descriptions of boxed warnings, contraindications, most frequent or severe adverse reactions, clinically significant drug interactions, and certain other warnings. The draft says FDA examined social science research concerning what consumers read, understood and recalled when presented with extensive information. ...